AVEX Foot Compression Device for Diabetic Patients (H-37962)
AVEX Footbeat - Micro-Mobile Foot Compression Device for Reducing Lower Extremity Edema in Patients With Diabetes: A Proof of Concept Study
Principal Investigator: Bijan Najafi, Ph.D.
The purpose of this study is to conduct an observational study with patients to assess whether the AVEX foot compression device can help improve lower extremity perfusion, while improving balance and spatio-temporal parameters of gait. In addition, we aim to assess the effectiveness of the Boa Technology ‘Clutch Reel’ at producing pre-set shoe tightening tension while enhancing the ease of wearing diabetic shoes with the AVEX insole and Clutch Reel, reducing skin friction, and improving patients' confidence in their gait, mobility, balance, and daily physical activities.
a) Males or females age 18-80 years old with history of type 1 or 2 diabetes and the ability and willingness to provide Informed consent
b) Patients at risk of developing diabetic foot ulcers
c) Patients willing to participate in all procedures and follow-up evaluations necessary to complete the study
d) Patients who have undergone lower extremity surgery / amputation may be enrolled into the study at the clinical judgment of the investigator.
a) Patients with severe peripheral vascular disease (ABI or ankle-brachial systolic pressure index <0.5)
b) Patients with diabetic foot ulcers in the plantar foot region
c) Patients with active wound infection or untreated osteomyelitis
d) Patients currently on immunosuppressive drugs
e) Pregnant or breastfeeding females (standard urine pregnancy done on women during physical exam procedures)
f) Patients with acute fractures of the foot
g) Patients with acute heart failure
h) Participants in an interventional study within the last 30 days
i) Patients who are non-ambulatory or unable to stand without help or walk a distance of at least six feet without assistance
j) Patients with major foot amputation
k) Patients unable or unwilling to participate in all procedures and follow-up evaluations
l) Patients with major foot deformities which won’t fit in the diabetic shoes